CompletedPhase 1

Safety of GH001 in Healthy Volunteers

Netherlands22 participantsStarted 2019-03-13

Plain-language summary

The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and its dose-related psychoactive effects in healthy volunteers. The study will evaluate single, ascending doses of GH001 in Part A and an individualized dosing regimen of GH001 in Part B.

Who can participate

Age range18 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject has a body mass index (BMI) in the range of 18.5 and 27.0 kg/m2 (inclusive); * Subject is in good general health in the opinion of the medical supervisor; * Subject is in good mental health in the opinion of the (clinical) psychologist as determined by the intake interview; Exclusion Criteria: * Has known allergies or hypersensitivity or any other contraindication to 5-MeO-DMT; * Has received any investigational medication within the last 1 month. * Has a medically significant condition, which renders the subject unsuitable for the study.

What they're measuring

The safety and tolerability of GH001

Timeframe: up to 7 days

The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale

Timeframe: Retrospectively assessed at 3 hours

Trial details

NCT IDNCT04640831

SponsorGH Research Ireland Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-10-04

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